UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030931 |
|---|---|
| Receipt number | R000034641 |
| Scientific Title | Preventive effects of ultrasound-guided obturator nerve block proximal approach on adductor muscle contraction during transurethral resection of the bladder tumor: a prospective, observational study |
| Date of disclosure of the study information | 2018/05/25 |
| Last modified on | 2019/11/20 14:25:35 |
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Basic information
Public title
Preventive effects of ultrasound-guided obturator nerve block proximal approach on adductor muscle contraction during transurethral resection of the bladder tumor: a prospective, observational study
Acronym
Preventive effects of ultrasound-guided obturator nerve block proximal approach on adductor muscle contraction during transurethral resection of the bladder tumor: a prospective, observational study
Scientific Title
Preventive effects of ultrasound-guided obturator nerve block proximal approach on adductor muscle contraction during transurethral resection of the bladder tumor: a prospective, observational study
Scientific Title:Acronym
Preventive effects of ultrasound-guided obturator nerve block proximal approach on adductor muscle contraction during transurethral resection of the bladder tumor: a prospective, observational study
Region
| Japan |
Condition
Condition
Bladder tumor
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To observe the preventive effects of ultrasound-guided obturator nerve block proximal approach on adductor muscle contraction during transurethral resection of the bladder tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Degree of lower limb movement during transurethral resection of the bladder tumor using socore; 1=no movement, 2=slight movement, 3=moderate movement, 4=severe movement, 5=perforation
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients who are schedulled for transurethral bladder tumor resection under spinal anesthesia.
2)Patients who need obturator nerve block for transurethral bladder tumor resection.
3)American Society of Anesthesiologists physical status 1~3
Key exclusion criteria
1)Peripheral neuropathy on lower limb
2)Allergy to local anesthetic used
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Shinichi |
| Middle name | |
| Last name | Sakura |
Organization
Shimane University Hospital
Division name
Operation department
Zip code
693-8501
Address
89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL
0853-20-2295
ssakura@med.shimane-u.ac.jp
Public contact
Name of contact person
| 1st name | Shinichi |
| Middle name | |
| Last name | Sakura |
Organization
Shimane University Hospital
Division name
Operation department
Zip code
693-8501
Address
89-1 Ennyacho, Izumo-city, Shimane, Japan
TEL
0853-20-2295
Homepage URL
ssakura@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shimane University Hospital, Clinical Trial Review Board
Address
89-1 Enya-cho, Izumo-shi, Shimane
Tel
0853-20-2515
kenkyu@med.shimane-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2017 | Year | 12 | Month | 13 | Day |
Date of IRB
| 2017 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 26 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We are going to observe preventive effects of ultrasound-guided obturator nerve block proximal approach on adductor muscle contraction during transurethral resection of the bladder tumor. Urologist will evaluate the adductor muscle contraction during surgery.
Management information
Registered date
| 2018 | Year | 01 | Month | 22 | Day |
Last modified on
| 2019 | Year | 11 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034641
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
